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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name pump, breast, powered
510(k) Number K212564
Device Name Electric Breast Pump
Guangdong Horigen Mother & Baby Products Co., Ltd.
No. 18, Pingnan Industrial Zone, Mianbei Street
Chaoyang District
Shantou,  CN 515100
Applicant Contact Changxin Chen
Guangzhou Osmunda Medical Device Technical Service Co., Ltd.
8-9th Floor, R&D Building, No.26 Qinglan Street, Panyu Distr
Guangzhou,  CN 510006
Correspondent Contact Olivia Meng
Regulation Number884.5160
Classification Product Code
Date Received08/13/2021
Decision Date 05/06/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No